FDA 510(k) Application Details - K003583

Device Classification Name	Assay, Porphyrin, Spectrophotometry, Lithium   More FDA Info for this Device
510(K) Number	K003583
Device Name	Assay, Porphyrin, Spectrophotometry, Lithium
Applicant	TRACE AMERICA, INC. 845 AVE. G EAST ARLINGTON, TX 76011 US Other 510(k) Applications for this Company
Contact	THOMAS DOLLAR Other 510(k) Applications for this Contact
Regulation Number	862.3560   More FDA Info for this Regulation Number
Classification Product Code	NDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2000
Decision Date	01/17/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review